Halozyme soars on European drug news

San Diego  Shares of Halozyme Therapeutics jumped 25 percent Friday after a favorable decision from a European regulatory committee.

A reformulated version of Roche’s drug Herceptin made with Halozyme technology was recommended for approval by the advisory Committee for Medicinal Products for Human Use.

Roche seeks to sell reformulated Herceptin for patients with HER2-positive breast cancer. The reformulated version is injected beneath the skin, saving time and providing convenience to patients and health care professionals. Herceptin is now given intravenously.

Shares of San Diego-based Halozyme closed at $7.95, up $1.58 for the day.

The company’s stock has been volatile. Shares rose 27 percent in December after Halozyme announced a deal to make injectable medicines for Pfizer. In August, after a delay in a U.S. marketing application for a reformulated immunotherapy drug from Baxter International, the shares fell by nearly half.

The Baxter drug, called HyQvia, received European approval in May. Product launch there is expected in July, said Gregory Frost, Halozyme’s chief executive.

Halozyme makes a recombinant enzyme called hyaluronidase that temporarily makes the subcutaneous area more permeable. This allows rapid injection of large-molecule biotech drugs such as Herceptin, which are otherwise not deliverable by that method. Roche also seeks European approval of the cancer drug MabThera, called Rituxan in the U.S.

The speed increase over IV infusion is dramatic, Frost said. An infusion of Herceptin can take 30 to 90 minutes; delivery with Halozyme’s technology takes two to five minutes. And delivery of Rituxan can be reduced from hours to five minutes.

It’s also easier and faster to prepare the subcutaneous dose than the IV form, Frost said.

Halozyme has one product approved in the United States. Called Hylenex, it’s a separate formulation of the enzyme. It’s approved to make the subcutaneous layer more permeable to fluid injections for hydrating patients. Hylenex is also approved to increase absorption of contrast agents for X-ray examination of the kidneys and the tubes that drain them, called ureters.

Approval of the reformulated Herceptin and Rituxan in Europe wouldn’t necessarily mean approval in the U.S. or other countries, Frost said.